CESAMET CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

NABILONE

Tilgængelig fra:

BAUSCH HEALTH, CANADA INC.

ATC-kode:

A04AD11

INN (International Name):

NABILONE

Dosering:

0.5MG

Lægemiddelform:

CAPSULE

Sammensætning:

NABILONE 0.5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Narcotic (CDSA II)

Terapeutisk område:

MISCELLANEOUS ANTIEMETICS

Produkt oversigt:

Active ingredient group (AIG) number: 0115009002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2004-09-13

Produktets egenskaber

PRODUCT MONOGRAPH
N
CESAMET
®
Nabilone
Capsules; 1 mg, 0.5 mg, 0.25 mg
ANTIEMETIC
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear West
Laval, Quebec
H7L 4A8
DATE OF REVISION:
May 24, 2019
Submission Control No.: 226983
_N_
_CESAMET_
_®_
_ Product Monograph _
_ Page 2 of 16_
NAME OF DRUG
N
CESAMET
®
capsules
(nabilone)
THERAPEUTIC CLASSIFICATION
Antiemetic Agent
ACTION
N
CESAMET
®
(nabilone) is a synthetic cannabinoid with antiemetic properties which
have been
found to be of value in the management of some patients with nausea
and vomiting associated
with cancer chemotherapy. It also has sedative and psychotropic
effects.
After oral administration, comparable peak plasma levels of nabilone
and of its carbinol
metabolite were attained within 2 hours. The combined plasma
concentrations of nabilone and of
its carbinol metabolite accounted for, at most, 10 to 20% of the total
radiocarbon concentration
in plasma. The plasma half-life of nabilone was approximately 2 hours,
while that of the total
radiocarbon was of the order of 35 hours.
Of the two major possible metabolic pathways, stereo-specific
enzymatic reduction and direct
enzymatic oxidation, the latter appears to be the more important in
man.
The drug and its metabolites are eliminated mainly in the feces
(approximately 65%) and to a
lesser extent in the urine (approximately 20%). The major excretory
pathway is the biliary
system.
INDICATIONS
ADULTS: > 18 YEARS
N
CESAMET
®
(nabilone) is indicated for the management of severe nausea and
vomiting
associated with cancer chemotherapy.
PEDIATRICS: < 18 YEARS
The safety and efficacy of
N
CESAMET
®
in the pediatric population have not been established
and its use is not recommended in this patient population.
GERIATRICS: > 65 YEARS
N
CESAMET
®
should be used with caution in the elderly (see PRECAUTIONS).
_N_
_CESAMET_
_®_
_ Product Monograph Page 3 of 16_
CONTRAINDICATIONS
N
CESAMET
®
(nabilone) is contraindicated in patients with known sensitivity to
marijuana or
other cannabinoid agents, and in those with a histor